A variety of techniques and instruments have been developed for use in the removal or repair of tissue in arteries and similar body passageways. A frequent objective of such techniques and instruments is the removal of atherosclerotic plaques in a patient's arteries. Atherosclerosis is characterized by the buildup of fatty deposits (atheromas) in the intimal layer (under the endothelium) of a patient's blood vessels. Very often over time, what initially is deposited as relatively soft cholesterol-rich atheromatous material hardens into a calcified atherosclerotic plaque. Such atheromas restrict the flow of blood, and therefore are often referred to as stenotic lesions or stenoses, the blocking material being referred to as stenotic material. If left untreated, such stenoses can cause angina, hypertension, myocardial infarction, strokes and the like.
Several kinds of atherectomy devices have been developed for attempting to remove some or all of such stenotic material. In one type of device, such as that shown in U.S. Pat. No. 5,092,873 (Simpson), a cylindrical housing, canned at the distal end of a catheter, has a portion of its side-wall cut out to form a hollow housing into which the atherosclerotic plaque can protrude when the device is positioned next to the plaque. An atherectomy blade, disposed within the housing, is then advanced the length of the housing to lance the portion of the atherosclerotic plaque that extends into the housing cavity. While such devices provide for directional control in selection of tissue to be excised, the length of the portion excised at each pass of the atherectomy blade is necessarily limited to the length of the cavity in the device--in turn, the length and relative rigidity of the housing limits the maneuverability and therefore the utility of the device in narrow and tortuous passageways such as coronary arteries.
Another approach which solves some of these problems involves the use of a rotating burr covered with an abrasive cutting material such as diamond grit (diamond particles or dust) carried at the distal end of a flexible drive shaft, similar to a dental abrading/polishing tool. Examples of such devices are illustrated in U.S. Pat. No. 4,990,134, (issued to Auth), as well as "Premier Two Striper.RTM. Gingival Curettage" (Abrasive Technology, Inc. 1982); "Premier Two Striper.RTM. Crown & Bridge Techniques" (Abrasive Technology, Inc. 1981); H. Gilmore, et. al, operative Dentistry (C. V. Mosby Company 1982, 4th ed.), pp. 64-65, 69, 348-350; R. Tupac, et al., "A Comparison of Cord Gingival Displacement With the Gingitage Technique," Journal of Prosthetic (Nov. 1981, pp.509-515); and Premier Presents Two Striper.RTM. Dental Diamond Instruments (Abrasive Technology, Inc. 1989). The burr in such devices is rotated at speeds in the range of 20,000 to 200,000 rpm or more, which, depending on the diameter of the burr, can provide surface speeds of the abrasive particles on the burr above or below 40 ft/sec. Auth claims that at surface speeds below 40 ft/sec the abrasive burr will remove hardened atherosclerotic material but will not damage normal elastic soft tissue of the vessel wall. Auth also admits that at surface speeds above 40 ft/sec the abrasive burr will remove both hardened and soft tissue. See, e.g., U.S. Pat. No. 4,990,134 at col. 3, lines 20-23. Unfortunately not all atherosclerotic plaques are hardened, calcified atherosclerotic plaques. Moreover, the mechanical properties of the soft plaques are very often quite close to the mechanical properties of the soft wail of the vessel. Thus, one cannot safely rely entirely on the differential cutting properties of such abrasive burrs to remove atherosclerotic material from an arterial wall, particularly where one is attempting to entirely remove all or almost all of the atherosclerotic material. See, e.g., Atherectomy, A Physicians Guide, (Strategic Business Development, Inc., 1990), pp. 89, 94-96. Furthermore, the Auth burr effectively blocks blood flow through the artery during the passage of the burr through the stenosis, thus limiting the amount of time of each pass across the stenosis to less than one minute (and perhaps as little as 10 seconds). See id. at pp. 95-96. Because the size of the particles removed by the Auth burr is very small (typically 5 microns or less), and because of the time limitations described above, in clinical practice, in order to remove a sufficient amount of tissue during each pass of the burr across the stenosis, the Auth burr is virtually always rotated at speeds of at least about 155,000 rpm. At such speeds a diamond dust covered burr with a diameter of 1.5 mm achieves a surface speed of 40 ft/sec, the very speed at which the differential cutting effect becomes limited, at best (i.e., the burr removes both hard and soft tissue).
The ability of diamond dust covered burrs to remove human soft tissue at high surface speeds (e.g., small diameter burrs rotated at about 200,000 rpm) has been known for some time and has been utilized in dentistry since at least the early 1980's to remove soft gum tissue (see, e.g., "Premier Two Striper.RTM. Gingival Curettage" (Abrasive Technology, Inc. 1982); "Premier Two Striper.RTM. Crown & Bridge Techniques" (Abrasive Technology, Inc. 1981); H. Gilmore, et. al, Operative Dentistry (C. V. Mosby Company 1982, 4th ed.), pp. 348-350; R. Tupac, et al., "A Comparison of Cord Gingival Displacement With the Gingitage Technique," Journal of Prosthetic Dentistry (Nov. 1981, pp.509-515).
Several problems have been recognized in use of the Auth-type of burr, however. First, although under some conditions the differential cutting properties of such burrs are effective to protect healthy tissue, in many circumstances the burr nevertheless can abrade at least a portion of the healthy tissue, creating a risk of perforation. This is particularly true at higher rotational speeds. A majority of atherosclerotic lesions are asymmetrical (i.e., the atherosclerotic plaque is thicker on one side of the artery than on the other). Moreover, pressure of the burr against the atherosclerotic plaque is achieved only by the use of a burr having a diameter slightly larger than the opening through the stenotic passageway. Thus, since the stenotic material will be entirely removed on the thinner side of an eccentric lesion before it will be removed on the other, thicker side of the lesion, during removal of the remaining thicker portion of the atherosclerotic plaque the burr necessarily will be engaging healthy tissue on the side which has been cleared--indeed, lateral pressure by such healthy tissue against the burr is required to keep the burr in contact with the remaining stenotic tissue on the opposite side of the passageway. For stenotic lesions that are entirely on one side of an artery (a relatively frequent condition), this means that the healthy tissue across from the stenotic lesion will be exposed to and in contact with the abrasive burr for substantially the entire procedure. Moreover, pressure from that healthy tissue against the burr will be, in fact, the only pressure urging the burr against the atherosclerotic plaque. Under these conditions, a certain amount of damage to the healthy tissue is almost unavoidable, even though undesirable, and there is a clear risk of perforation. Thus, in clinical practice (balancing safety and residual stenosis), physicians rarely use a burr diameter of more than 2 mm, even on patients where the original diameter of the coronary artery lumen is estimated to be 3 mm. See, e.g., Atherectomy, A Physicians Guide, (Strategic Business Development, Inc., 1990), p. 96. These risks are enhanced at high rotational speeds where the differential cutting phenomenon is significantly diminished.
As indicated above, in clinical practice the opening of the stenosis of coronary (heart) arteries is performed very fast and thus very large numbers of small particles of stenotic material (estimated to be 1,000,000 per cubic mm of stenotic material removed--see id. at p. 92) are released into the coronary artery within a very short period of time. Although individually the particles (typically in the range of 5 microns) can easily pass through the capillaries, when such large numbers of such particles are released within a very short period of time it is very possible that there is a risk that they may at least temporarily occlude the capillaries. This may explain the heart pain which is not infrequently experienced by patients immediately after the Auth-type burr is passed across the stenosis, as well as elevated levels of enzymes indicative of myocardial ischemia (such as CPK) which have been documented in some patients after the Auth-type burr procedure. See id. at p. 95. There is yet a further disadvantage to the traditional rotating burr apparatus, particularly the device depicted in the '134 Auth patent. When such a device is used to open an arterial passageway which is quite narrow, the burr utilized must initially be relatively small. When the small-sized burr has been completely advanced through the stenosis, however, it cannot widen the passageway to a diameter larger than the diameter of the burr itself, and the burr must be exchanged for a larger diameter burr to continue the widening process. It is not unusual, and in fact is quite common, that at least two, and sometimes three or four progressively larger burrs are necessary to complete the task. Since the burrs are permanently attached to the flexible drive shaft, which in turn is permanently attached to the drive motor (or air turbine) and the associated proximal controls for the device, changing burr sizes means essentially exchanging the entire device (except for the guide wire) for a new one. Currently the cost of such devices is quite high, and the need to use multiple burr sizes multiplies this cost, making the procedure quite expensive.
It would therefore be advantageous to provide an abrasive burr based instrument which can provide directional control of removal of stenotic tissue allowing one to effectively remove eccentrically located stenotic material (e.g., atherosclerotic plaque) without any risk of damage (and thus risk of perforation) to normal vascular wall not covered with stenotic material. It would also be advantageous to provide such an instrument that would not completely occlude the blood flow through an artery during the atherectomy procedure, thus, not limiting the time available to the physician to open the stenosis. Furthermore, it would be advantageous to provide such an instrument that would allow slower, controlled release of particles of stenotic material into the capillaries over a longer period of time, thus reducing or eliminating the possibility of temporary cardiac ischemia (as evidenced by CPK elevation) and heart pain associated with passage of the burr across the stenosis. Also, it would be advantageous to provide a small diameter burr-based instrument capable of opening stenoses in large diameter peripheral arteries (such as the femoral and iliac arteries) without resorting to entry through a cut-down on the femoral artery. Finally, it would be extremely advantageous to provide such a device that can accomplish these objectives and also allow one to widely open stenotic vessels (e.g., atherosclerotic arteries) to their large original diameter without having to use multiple burrs of successively larger diameters, thus reducing the number of very expensive instruments needed for each procedure.